Respiratory DistressNCT06826053
The Smell of Breast Milk and Therapeutic Positions in Comfort
A study testing Therapeutic position and Therapeutic position + smell breast milk in people with Respiratory Distress, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Before starting the data collection process, a pilot study was conducted with 10 preterm newborns, five in the safe swaddling group and five in the control group, to evaluate the comprehensibility of the questionnaire form and the feasibility of the application. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Respiratory Distress
- What is being tested?
- Therapeutic position and Therapeutic position + smell breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- NICU admission immediately after birth.
- The babies were term births (births at 38 weeks and above).
- The baby was not given analgesics and/or sedatives.
- The baby had spontaneous breathing.
- Families\' acceptance to participate in the study.
Who cannot join
- With a thoracic tube, umbilical vein catheter or dialysis catheter.
- With active infection.
- Tachypnea and unstable oxygen saturation ≤ 90%.
- Receiving sedation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Therapeutic Positions and the Smell of Breast Milk on Comfort and Vital Signs in Term Neonates With Respiratory Distress
Before starting the data collection process, a pilot study was conducted with 10 preterm newborns, five in the safe swaddling group and five in the control group, to evaluate the comprehensibility of the questionnaire form and the feasibility of the application. The newborns included in the pilot study were not included in the study.
At the beginning of the study, parents of newborns who met the sample selection criteria were informed about the purpose and content of the study and informed consent was obtained from those who agreed to participate in the study. Data were obtained from parents of infants 38 weeks and older who were hospitalized in the Tertiary NICU and who met the sample selection criteria by using data collection tools. Firstly, parents were informed about the study through the "Information and Informed Consent Form" (Appendix-E). They were included in the study if they volunteered. Written informed consent was obtained from the parents who volunteered to participate in the study. Data were collected using "Data Collection Tools" prepared by the researcher.
Read more
Newborns will be randomly divided into two groups;
- Group 1: Therapeutic position
- Group 2: Therapeutic position + the smell of breast milk Number, percentage, mean and standard deviation will be used in the descriptive statistics of the study. The normality of the data will be evaluated with the Kolmogrow Smirnow test. Kappa analysis will be used in the evaluation of inter-observer agreement. Chi-square test will be used for the comparison of categorical data, t test and Anova in independent groups will be used for the comparison of normally distributed data, Friedman, Wilcoxon, Mann Whitney U and Kruskal Wallis tests will be used for the comparison of non-normally distributed data. Within-group evaluation will be evaluated by repeated measures analysis of variance. Significance level p\<0.05 will be accepted.
Continuous data will be shown as mean ± standard deviation for normally distributed data, median and 25-75th quartile for non-normally distributed data, and frequency and percentage for categorical data. For comparisons of differences between categorical variables by groups, Pearson chi-square test will be used for RxC tables with expected observations of 5 and above and Fisher Freeman Halton test will be used for RxC tables with expected observations below 5.
Read the detailed description
Ethical and institutional permissions were obtained before starting to collect the data. Written consent will be obtained from all parents via a voluntary consent form. Newborns will be randomly selected into 2 groups.
Group 1: term neonates in four different therapeutic positions (prone-right lateral-supine-left lateral). The positions of the newborns will be changed every two hours in sequence. In addition, peak heart rate, respiration, oxygen saturation, comfort (2 observers), pain (2 observers), distress (2 observers) will be evaluated every 30 minutes for two hours. A total of 5 measurements and evaluations will be performed.
Group 2: Therapeutic position + the smell of breast milk . The positions of the newborns will be changed every two hours in sequence. Newborns in this group will also be made to smell the odor of breast milk. For breast milk odor, approximately 3-5 cc of breast milk obtained from each baby\'s own mother\'s milk will be dripped onto 4x4 gauze swabs. These gauze pads dripped with breast milk will be placed at a distance of approximately 10 cm from the baby\'s nose. Then, peak heart rate, respiration, oxygen saturation, comfort (2 observers), pain (2 observers), distress (2 observers) values of the newborn will be evaluated every 30 minutes for two hours. A total of 5 measurements and evaluations will be performed.
Hypotheses of the Study H1: Different therapeutic positions given to newborns have an effect on respiratory rate.
H2: Different therapeutic positions given to newborns have an effect on peak heart rate.
H3: Different therapeutic positions given to newborns have an effect on oxygen saturation.
H4: Different therapeutic positions given to newborns have an effect on comfort level.
H5: Different positions given to newborns and breast milk odor have an effect on respiratory rate.
H6: Different positions given to newborns and breast milk odor have an effect on peak heart rate.
H7: Different positions given to newborns and breast milk odor have an effect on oxygen saturation.
H8: Different positions given to newborns and breast milk odor have an effect on comfort level.
H9: There is a significant difference between the two groups in terms of respiratory rate of newborns.
H10: There is a significant difference between the two groups in terms of peak heart rate of newborns.
H11: There is a significant difference between the two groups in terms of oxygen saturation of newborns.
H12: There is a significant difference between the two groups in terms of comfort level of newborns.
- Conditions
- Respiratory Distress
- Being tested
- Therapeutic position, Therapeutic position + smell breast milk
- Keywords
- respiratory distress, therapeutic position, the smell of breast milk, term neonatal
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic positionOther
each newborn was given four different therapeutic positions in sequence.
Therapeutic position + smell breast milkOther
each newborn will be given four different therapeutic positions in sequence and will be made to smell the scent of breast milk.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic position group | Experimental | Therapeutic group Receives: Other: Therapeutic position |
| Therapeutic position + smell of breast milk | Experimental | Therapeutic position + smell of breast milk Receives: Other: Therapeutic position + smell breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
heart rate
Measured: every 30 minutes for two hours
oxygen saturation values
oxygen saturation values
Measured: every 30 minutes for two hour
respiratory rate
respiratory rate
Measured: every 30 minutes for two hours
Secondary outcomes (1)
Neonatal Comfort Behavior Scale Score
comfort scale
Measured: every 30 minutes for two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Mar 2024
- Primary completion1 Apr 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Sonay Turkmen, Prof.Dr, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826053
- Sponsor's protocol ID
- smell of breast milk
- Status last verified
- Feb 2025
- First submitted
- 8 Aug 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Positions and the Smell of Breast Milk on Comfort and Vital Signs in Term Neonates With Respiratory Distress
- ClinicalTrials.gov ID
- NCT06826053
- Acronym / sponsor ID
- smell of breast milk
- Conditions
- Respiratory Distress
- Keywords
- respiratory distress, therapeutic position, the smell of breast milk, term neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Before starting the data collection process, a pilot study was conducted with 10 preterm newborns, five in the safe swaddling group and five in the control group, to evaluate the comprehensibility of the questionnaire form and the feasibility of the application. The newborns included in the pilot study were not included in the study.
At the beginning of the study, parents of newborns who met the sample selection criteria were informed about the purpose and content of the study and informed consent was obtained from those who agreed to participate in the study. Data were obtained from parents of infants 38 weeks and older who were hospitalized in the Tertiary NICU and who met the sample selection criteria by using data collection tools. Firstly, parents were informed about the study through the "Information and Informed Consent Form" (Appendix-E). They were included in the study if they volunteered. Written informed consent was obtained from the parents who volunteered to participate in the study. Data were collected using "Data Collection Tools" prepared by the researcher.
Newborns will be randomly divided into two groups;
- Group 1: Therapeutic position
- Group 2: Therapeutic position + the smell of breast milk Number, percentage, mean and standard deviation will be used in the descriptive statistics of the study. The normality of the data will be evaluated with the Kolmogrow Smirnow test. Kappa analysis will be used in the evaluation of inter-observer agreement. Chi-square test will be used for the comparison of categorical data, t test and Anova in independent groups will be used for the comparison of normally distributed data, Friedman, Wilcoxon, Mann Whitney U and Kruskal Wallis tests will be used for the comparison of non-normally distributed data. Within-group evaluation will be evaluated by repeated measures analysis of variance. Significance level p\<0.05 will be accepted.
Continuous data will be shown as mean ± standard deviation for normally distributed data, median and 25-75th quartile for non-normally distributed data, and frequency and percentage for categorical data. For comparisons of differences between categorical variables by groups, Pearson chi-square test will be used for RxC tables with expected observations of 5 and above and Fisher Freeman Halton test will be used for RxC tables with expected observations below 5.
Detailed description
Ethical and institutional permissions were obtained before starting to collect the data. Written consent will be obtained from all parents via a voluntary consent form. Newborns will be randomly selected into 2 groups.
Group 1: term neonates in four different therapeutic positions (prone-right lateral-supine-left lateral). The positions of the newborns will be changed every two hours in sequence. In addition, peak heart rate, respiration, oxygen saturation, comfort (2 observers), pain (2 observers), distress (2 observers) will be evaluated every 30 minutes for two hours. A total of 5 measurements and evaluations will be performed.
Group 2: Therapeutic position + the smell of breast milk . The positions of the newborns will be changed every two hours in sequence. Newborns in this group will also be made to smell the odor of breast milk. For breast milk odor, approximately 3-5 cc of breast milk obtained from each baby\'s own mother\'s milk will be dripped onto 4x4 gauze swabs. These gauze pads dripped with breast milk will be placed at a distance of approximately 10 cm from the baby\'s nose. Then, peak heart rate, respiration, oxygen saturation, comfort (2 observers), pain (2 observers), distress (2 observers) values of the newborn will be evaluated every 30 minutes for two hours. A total of 5 measurements and evaluations will be performed.
Hypotheses of the Study H1: Different therapeutic positions given to newborns have an effect on respiratory rate.
H2: Different therapeutic positions given to newborns have an effect on peak heart rate.
H3: Different therapeutic positions given to newborns have an effect on oxygen saturation.
H4: Different therapeutic positions given to newborns have an effect on comfort level.
H5: Different positions given to newborns and breast milk odor have an effect on respiratory rate.
H6: Different positions given to newborns and breast milk odor have an effect on peak heart rate.
H7: Different positions given to newborns and breast milk odor have an effect on oxygen saturation.
H8: Different positions given to newborns and breast milk odor have an effect on comfort level.
H9: There is a significant difference between the two groups in terms of respiratory rate of newborns.
H10: There is a significant difference between the two groups in terms of peak heart rate of newborns.
H11: There is a significant difference between the two groups in terms of oxygen saturation of newborns.
H12: There is a significant difference between the two groups in terms of comfort level of newborns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic position group | Experimental | Other: Therapeutic positionTherapeutic group |
| Therapeutic position + smell of breast milk | Experimental | Other: Therapeutic position + smell breast milkTherapeutic position + smell of breast milk |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- NICU admission immediately after birth.
- The babies were term births (births at 38 weeks and above).
- The baby was not given analgesics and/or sedatives.
- The baby had spontaneous breathing.
- Families\' acceptance to participate in the study.
Key exclusion criteria (4 listed)
- With a thoracic tube, umbilical vein catheter or dialysis catheter.
- With active infection.
- Tachypnea and unstable oxygen saturation ≤ 90%.
- Receiving sedation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic positioneach newborn was given four different therapeutic positions in sequence. | Other | Therapeutic position group |
| Therapeutic position + smell breast milkeach newborn will be given four different therapeutic positions in sequence and will be made to smell the scent of breast milk. | Other | Therapeutic position + smell of breast milk |
Primary outcome
heart rate
Time frame: every 30 minutes for two hours
heart rate
oxygen saturation values
Time frame: every 30 minutes for two hour
oxygen saturation values
respiratory rate
Time frame: every 30 minutes for two hours
respiratory rate
1 secondary outcome
Neonatal Comfort Behavior Scale Score
Time frame: every 30 minutes for two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Respiratory Distress
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic position and Therapeutic position + smell breast milk in people with Respiratory Distress, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate (time frame: every 30 minutes for two hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.